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New TB Treatment Options on Horizon

MedPageToday, 2012

WASHINGTON -- After nearly 50 years, the drug development pipeline for new tuberculosis (TB) treatments is finally opening up again, according to infectious disease specialists. The first drug to treat tuberculosis was developed in 1943, and for 20 years, only a handful of others were developed. About 8.8 million people become infected with TB each year, and 1.4 million die from it, mostly in developing countries.And drug resistance has become an increasing problem -- in large part because between 20% and 30% of people who start the long, complex treatment course stop before it's complete. But, although the National Institutes of Health (NIH) budget has been flat since 2008, funding within the agency for TB research has increased, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told reporters at a Monday afternoon briefing on the state of TB research. "For the first time in a very long time, the TB pipeline is showing significant progress," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research (CDER), said at the briefing, which was sponsored by the TB Alliance. Eradicating TB will rely on having novel therapies, not just the same drugs and diagnostics that have been around since the early 1900s, said Robert Clay, MD, deputy assistant administrator for the Global Health Bureau of USAID.The trial is testing three drugs -- novel agents PA-824 and pyrazinamide, as well as the commonly-used drug moxifloxacin.It is taking place in Africa and South America among a mixed group of 250 TB patients, some of whom are drug-resistant, some of whom are drug-sensitive, and some of whom are neither. The trial is being funded by the TB Alliance, Bayer, Novartis, and USAID, and draws on early research funded by the NIH, the TB Alliance, and the Bill and Melinda Gates Foundation, said Mel Spigelman, MD, president and CEO of the TB Alliance. If the data pans out, the treatment regimen for TB could be reduced to a four-month, once-daily oral regimen and costs of treatment cut by 90%, he said.